510(k) K162877 ยท CBK Ventilator, Continuous, Facility Use
VOCSN Unified Respiratory System
| Applicant | Ventec Life Systems, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Oct 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162877
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN+Pro,
Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN+Pro (Japan),
Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC+Pro
Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC+Pro (Japan)
Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN
Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN (Japan)
Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VCSN+Pro
Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. V+Pro
Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC
Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC(Japan)
Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Jun 23, 2026 | Ventec Life Systems, Inc. VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 Open, Classified |
CBK | None listed |
| May 1, 2026 | Ventec Life Systems, Inc. VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 Open, Classified |
NOU | None listed |
| Feb 26, 2025 | Ventec Life Systems, Inc. VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002 Open, Classified |
CBK | None listed |
| Feb 23, 2024 | Ventec Life Systems, Inc. VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermi Open, Classified |
CBK | None listed |
| Jun 21, 2021 | Ventec Life Systems, Inc. Ventec Life Systems VOCSN Multi-Function Ventilator
Model/Version/Catalog Number:
V+O+C+S+N+Pro/English/PRT-00490-001;
V+O+C+S+N+Pro/Japan/PRT-00490-100;
V+C+Pro/English/PRT-00900-001;
V+C+Pro/Japan/ Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.